Montelukast Mylan 10 mg film-coated tablets

The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 April 2020 SmPC

Reasons for updating

Change to section 2 - Qualitative and quantitative composition

Change to section 3 - Pharmaceutical form

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects

Change to section 5.1 - Pharmacodynamic properties

Change to section 6.1 - List of excipients

Change to section 6.5 - Nature and contents of container

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 10 April 2020 PIL

Reasons for updating

Change to section 2 - excipient warnings

Change to section 4 - possible side effects

Change to section 4 - how to report a side effect

Change to section 6 - what the product contains

Change to section 6 - what the product looks like and pack contents

Change to section 6 - date of revision

Updated on 3 January 2020 SmPC

Reasons for updating

Change to section 6.5 - Nature and contents of container

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 January 2020 PIL

Reasons for updating

Change to section 6 - what the product looks like and pack contents

Change to section 6 - date of revision

Updated on 16 September 2019 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Change to section 4 - possible side effects

Change to section 6 - date of revision

Updated on 16 September 2019 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 February 2017 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.6 - Pregnancy and lactation

Change to section 4.7 - Effects on ability to drive and use machines

Change to Section 4.8 – Undesirable effects - how to report a side effect

Change to section 4.9 - Overdose

Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration

Posology The recommended dosage for adult patients and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10 -mg tablet daily to be taken in the evening.

Paediatric populationDo not give Montelukast Mylan 10 mg film-coated tablets are not appropriate forto children less thanand adolescents under the age of 15 years of age. The safety and efficacy of montelukast tablets in children less than 15 years has not been established.Further pharmaceutical forms/strengths of the active substance montelukast are available. 4 mg & 5 mg chewable tablets can be used to treat paediatric patients from 2 to 145 years of age and 6 to 14 years of age respectively. 4 mg granules may be available for paediatric patients 6 months to 5 years of age.

4.6 Fertility, pregnancy and lactation

Breast-feedingStudies in rats have shown that montelukast is excreted in milk (see section 5.3). It is not known if montelukast/metabolites isare excreted in human milk.

4.7 Effects on ability to drive and use machines

Montelukast has no or negligible influence on theis not expected to affect a patient's ability to drive and usea car or operate machinersy. However, in very rare cases, individuals have reported drowsiness or dizziness.

4.8 Undesirable effects

Montelukast has been evaluated in clinical studies as follows:

• 10 mg film-coated tablets in approximately 4000 adult and adolescent asthmatic patients 15 years of age and older. • 10 mg film-coated tablets in approximately 400 adult and adolescent asthmatic patients with seasonal allergic rhinitis 15 years of age and older. • 5 mg chewable tablets in approximately 1,750 paediatric asthmatic patients 6 to 14 years of age.

Body System Class

Adult Patients

15 years and older

(two 12-week studies; n=795)

Paediatric Patients

6 to 14 years old

(one 8-week study; n=201)

(two 56-week studies;n=615)

Nervous system disorders

headache

headache

Gastrointestinal disorders

abdominal pain

With prolonged treatment in clinical trials with a limited number of adult patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.

Post-marketing ExperienceTabulated list of Adverse Reactions
Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific Adverse Experience TermReactions, in the table below. Frequency Categories were estimated based on relevant clinical trials.

System Organ Class

AdverseExperienceTermReactions

Frequency Category*

* Frequency Category: Defined for each Adverse Experience TermReaction by the incidence reported in the clinical trials data base: Very Common (≥ 1/10), Common (≥
1/100 to <1/10), Uncommon (≥ 1/1,000 to <1/100), Rare (≥ 1/10,000 to <1/1,000), Very Rare (<1/10,000).

4.9 OverdoseNo specific information is available on the treatment of overdose with montelukast. In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to patients for 22 weeks and in short term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.

Management of overdoseNo specific information is available on the treatment of overdose with montelukast.
It is not known whether montelukast is dialysable by peritoneal- or hemo-dialysis.

5.1 Pharmacodynamic properties

Clinical efficacy and safety

A clinical study was conducted to evaluate montelukast for the symptomatic treatment of seasonal allergic rhinitis in adult asthmatic patients 15 years of age and older with concomitant seasonal allergic rhinitis. In this study, montelukast 10 mg tablets administered once daily demonstrated a statistically significant improvement in the Daily Rhinitis Symptoms score, compared with placebo. The Daily Rhinitis Symptoms score is the average of the Daytime Nasal Symptoms score (mean of nasal congestion, rhinorrhea, sneezing, nasal itching) and the Nighttime Symptoms score (mean of nasal congestion upon awakening, difficulty going to sleep, and nighttime awakenings scores). Global evaluations of allergic rhinitis by patients and physicians were significantly improved, compared with placebo. The evaluation of asthma efficacy was not a primary objective in this study.

Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV1 22.33% for montelukast vs. 32.40% for placebo; time to recovery to within 5% of baseline FEV1 44.22 min vs. 60.64 min). This effect was consistent throughout the 12-week study period. Reduction in EIB was also demonstrated in a short term study in paediatric patients (maximal fall in FEV1 18.27% vs. 26.11%; time to recovery to within 5% of baseline FEV1 17.76 min vs. 27.98 min). The effect in both studies was demonstrated at the end of the once-daily dosing interval.

5.2 Pharmacokinetic properties

Biotransformation
Montelukast is extensively metaboliszed. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children.

Updated on 16 February 2017 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 14 February 2017 PIL

Reasons for updating

New PIL for new product

Updated on 14 February 2017 PIL

Reasons for updating

Change to section 1 - what the product is used for

Change to section 2 - what you need to know - warnings and precautions

Change to section 2 - use in children and adolescents

Change to section 3 - dose and frequency

Change to section 3 - use in children/adolescents

Change to section 3 - how to take/use

Change to section 4 - possible side effects

Change to section 6 - manufacturer

Change to section 6 - date of revision

Updated on 16 July 2015 SmPC

Reasons for updating

Change to section 4.1 - Therapeutic indications

Change to section 4.2 - Posology and method of administration

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.6 - Pregnancy and lactation

Change to Section 4.8 – Undesirable effects - how to report a side effect

Change to section 5.1 - Pharmacodynamic properties

Change to section 5.2 - Pharmacokinetic properties

Change to section 6.1 - List of excipients

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

section 4.1Montelukast is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting beta-agonists provide inadequate clinical control of asthma.

Montelukast Mylan 10mg film-coated tablets are indicated in adults and adolescents 15 years of age and older.

section 4.2

Posology

The dosage for adult patients and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10-mg tablet daily to be taken in the evening.

No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency, or mild to moderate hepatic impairment.

Method of administration

For oral use.

Montelukast may be taken with or without food.

section 4.4

If an acute attack occurs, a short-acting inhaled beta-agonist should be used. Patients should seek their doctors' advice as soon as possible if they need more inhalations of short-acting beta-agonists than usual.

The film-coated tablets also contain sunset yellow (E110), which may cause allergic reactions.

section 4.6

Limited data from available pregnancy databases do not suggest a causal relationship between montelukast and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.

section 4.8

• 10 mg film-coated tablets in approximately 4000 adult and adolescent asthmatic patients 15 years of age and older.

•10 mg film-coated tablets in approximately 400 adult and adolescent asthmatic patients with seasonal allergic rhinitis 15 years of age and older.

Updated on 11 March 2014 SmPC

Reasons for updating

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.6 - Pregnancy and lactation

Change to section 4.7 - Effects on ability to drive and use machines

Change to section 4.8 - Undesirable effects

Change to Section 4.8 – Undesirable effects - how to report a side effect

Change to section 5.2 - Pharmacokinetic properties

Change to section 6.6 - Special precautions for disposal and other handling

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2
Dosage changed to Posology
Montleukast may be taken with or without food-removed
Montelukast Mylan should not be used concomitanlty with other products containing the same active ingredient, montelukst-removed
for the elderly-removed
Montelukast Mylan can be added to a patients exisiting treatment regimen-removed
Inhaled corticosteroids paragraph updated.

Updated on 8 July 2013 SmPC

Reasons for updating

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.6 - Pregnancy and lactation

Change to section 4.7 - Effects on ability to drive and use machines

Change to section 4.8 - Undesirable effects

Change to section 5.2 - Pharmacokinetic properties

Change to section 6.5 - Nature and contents of container

Change to section 9 - Date of renewal of authorisation

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$04.2 Posology and method of administration$0$0$0$0$0Added under General recommendations -$0$0Montelukast may be taken with or without food. $0$0$0$0$0Added information for paediatric -$0$04 mg & 5 mg chewable tablets can be used to treat paediatric patients from 2 to 14 years of age.$0$0$0$0$0$0$0$04.5 Interaction with other medicinal products and other forms of interaction$0$0$0$0$0Added - $0$0In vitro studies have shown that montelukast is a substrate of CYP 2C8, and to a less significant extent, of 2C9, and 3A4. In a clinical drug-drug interaction study involving montelukast and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) gemfibrozil increased the systemic exposure of montelukast by 4.4-fold. No routine dosage adjustment of montelukast is required upon co-administration with gemfibrozil or other potent inhibitors of CYP 2C8, but the physician should be aware of the potential for an increase in adverse reactions.$0$0$0$0$0Based on in vitro data, clinically important drug interactions with less potent inhibitors of CYP 2C8 (e.g., trimethoprim) are not anticipated. Co-administration of montelukast with itraconazole, a strong inhibitor of CYP 3A4, resulted in no significant increase in the systemic exposure of montelukast.$0$0$0$0$0$0$0$04.6 Pregnancy and lactation$0$0$0$0$0Changed the term "nursing mothers" to "breast-feeding"$0$0$0$0$0$0$0$04.7 Effects on ability to drive and use machines$0$0$0$0$0Removed -$0$0No studies on the effects on the ability to drive and use machines have been reported.$0$0$0$0$0$0$0$04.8 Undesirable effects$0$0$0$0$0Added - $0$0Post-marketing Experience$0$0Adverse reactions reported in post-marketing use are listed, by System Organ Class and specific Adverse Experience Term, in the table below. Frequency Categories were estimated based on relevant clinical trials.$0$0$0$0$0Side effects put into table with frequency.$0$0$0$0$0$0$0$05.2 Pharmacokinetic properties$0$0$0$0$0Added - $0$0Cytochrome P450 2C8 is the major enzyme in the metabolism of montelukast. Additionally CYP 3A4 and 2C9 may have a minor contribution, although itraconazole, an inhibitor of CYP 3A4, was shown not to change pharmacokinetic variables of montelukast in healthy subjects that received 10 mg montelukast daily. Based on in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6. The contribution of metabolites to the therapeutic effect of montelukast is minimal. $0$0$0$0$0Removed - $0$0In vitro studies using human liver microsomes indicate that cytochrome P450 3A4, 2A6 and 2C9 are involved in the metabolism of montelukast. Based on further in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6. $0$0$0$0$0$0$0$06.5 Nature and contents of container$0$0$0$0$0Added -$0$0Aluminium/Aluminium perforated unit dose blisters within a cardboard carton containing pack sizes of 28 x 1 film-coated tablets.$0$0$0$0$0$0$0$0$0$0$0(Internal Ref: CRN 2122601 Renewal R1) $0

Updated on 8 July 2013 PIL

Reasons for updating

Change to, or new use for medicine

Change to warnings or special precautions for use

Change to side-effects

Change to drug interactions

Change to information about driving or using machinery

Change to further information section

Change due to harmonisation of PIL

Updated on 7 March 2013 SmPC

Reasons for updating

New SPC for new product

New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)